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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Shoreline ASC - 10889981127121

Implant Assembly/Packing block
SEASPINE ORTHOPEDICS CORPORATION
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block

Vu a-POD Prime NanoMetalene - 10889981125882

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
33-40-0141
In Commercial Distribution

  • 10889981125882 ()
33-40-0141

  • Bone graft packing block

Vu aPod™ - L - 10889981121471

Graft Block
SEASPINE ORTHOPEDICS CORPORATION
31-40-0142
In Commercial Distribution

  • 10889981121471 ()
31-40-0142

  • Bone graft packing block

Zuma-C - 10889981120733

Zuma-C Universal Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7092
In Commercial Distribution

  • 10889981120733 ()

  • N/A
95-7092

  • Bone graft packing block

Zuma - 10889981120627

Graft Packing Block, 38mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
95-5193
In Commercial Distribution

  • 10889981120627 ()

  • 38mm x 26mm
95-5193

  • Bone graft packing block

G-EO - 07640174420032

Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system

G-EO System - 07640174420018

Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual

Small Pacer - 00850001752244

Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual

Mini Pacer - 00850001752237

Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

QIAstat-Dx® Respiratory Panel - 04053228033905

No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Health o meter professional - 00851628008066

Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic

DEPTHALON - 00650551150701

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 28.7MM RECORDING DEPTH, 5.33MM SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-147
In Commercial Distribution

  • 00650551150701 ()


  • Depth electrode

DEPTHALON - 00650551150695

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 37MM RECORDING DEPTH, 7MM SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-146
In Commercial Distribution

  • 00650551150695 ()


  • Depth electrode

DEPTHALON - 00650551150626

PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 61.55MM RECORDING DEPTH, 3.97MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-16-136
In Commercial Distribution

  • 00650551150626 ()


  • Depth electrode

DEPTHALON - 00650551150619

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 19.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-131
In Commercial Distribution

  • 00650551150619 ()


  • Depth electrode

DEPTHALON® - 00650551098386

MICROWIRE DEPTH ELECTRODE, 8 MACRO CONTACTS, 24 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-08-24-001
In Commercial Distribution

  • 00650551098386 ()

  • Recording Depth 34.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 46 Centimeter
  • Contact Size 2 Millimeter
2104-08-24-001

  • Depth electrode

DEPTHALON® - 00650551098362

MICROWIRE DEPTH ELECTRODE, 5 MACRO CONTACTS, 20 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-05-20-02-IL
In Commercial Distribution

  • 00650551098362 ()

  • Recording Depth 19.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 16.5 Centimeter
  • Contact Size 1.5 Millimeter
2104-05-20-02-IL

  • Depth electrode

DEPTHALON® - 00650551098133

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-154
In Commercial Distribution

  • 00650551098133 ()

  • Main Tube Length 32 Centimeter
  • Spacing 2.4 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154

  • Depth electrode

DEPTHALON® - 00650551098126

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-153
In Commercial Distribution

  • 00650551098126 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153

  • Depth electrode

DEPTHALON® - 00650551098119

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-152
In Commercial Distribution

  • 00650551098119 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152

  • Depth electrode

DEPTHALON® - 00650551098102

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-151
In Commercial Distribution

  • 00650551098102 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151

  • Depth electrode

DEPTHALON® - 00650551098096

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-141
In Commercial Distribution

  • 00650551098096 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-141

  • Depth electrode

DEPTHALON® - 00650551098089

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-131
In Commercial Distribution

  • 00650551098089 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 54.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-131

  • Depth electrode

DEPTHALON® - 00650551098072

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-131
In Commercial Distribution

  • 00650551098072 ()

  • Main Tube Length 60 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-131

  • Depth electrode

DEPTHALON® - 00650551098065

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-131
In Commercial Distribution

  • 00650551098065 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 40.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-131

  • Depth electrode

DEPTHALON® - 00650551098058

DEPTH ELECTRODE, PLATINUM, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-10-IL-SS-M2
In Commercial Distribution

  • 00650551098058 ()

  • Main Tube Length 32 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
2102-10-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551098041

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-131
In Commercial Distribution

  • 00650551098041 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 35 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-131

  • Depth electrode

DEPTHALON® - 00650551098034

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-099
In Commercial Distribution

  • 00650551098034 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-099

  • Depth electrode

DEPTHALON® - 00650551098027

DEPTH ELECTRODE, PLATINUM, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-10-061
In Commercial Distribution

  • 00650551098027 ()

  • Main Tube Length 32 Centimeter
  • Spacing 11 Millimeter
  • Recording Depth 119 Millimeter
  • Contact Length 2 Millimeter
2102-10-061

  • Depth electrode

DEPTHALON® - 00650551098010

DEPTH ELECTRODE, PLATINUM, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-10-036
In Commercial Distribution

  • 00650551098010 ()

  • Main Tube Length 36 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
2102-10-036

  • Depth electrode

DEPTHALON® - 00650551098003

DEPTH ELECTRODE, PLATINUM, 8 CONTACT, IOM CONNECTOR
PMT CORPORATION
2102-08-132
In Commercial Distribution

  • 00650551098003 ()

  • Main Tube Length 213 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 37 Millimeter
  • Contact Length 2 Millimeter
2102-08-132

  • Depth electrode

DEPTHALON® - 00650551097990

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-08-131
In Commercial Distribution

  • 00650551097990 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-131

  • Depth electrode

DEPTHALON® - 00650551097976

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-102
In Commercial Distribution

  • 00650551097976 ()

  • Main Tube Length 35 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 27 Millimeter
  • Contact Length 2 Millimeter
2102-06-102

  • Depth electrode

DEPTHALON® - 00650551097969

sEEG, PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-06-101
In Commercial Distribution

  • 00650551097969 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 19.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-06-101

  • Depth electrode
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